FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • Cybersecurity Among Biggest Challenges For Pharma Firms Incorporating Digital Health Technologies
    Cybersecurity Among Biggest Challenges For Pharma Firms Incorporating Digital Health Technologies

    This is the second of two articles focusing on the issues that pharma companies face when moving into the digital health space. In the first installment, the development process, agency guidance, and the type of quality oversight needed for software incorporated into medical device and combination products were explored. This part focuses on the importance of cybersecurity and software maintenance, how time scales and methods of execution differ from those in traditional pharma, how agile software development works, and how to avoid potential pitfalls.

  • Biosimilar Coverage By The VA — What You Need To Know
    Biosimilar Coverage By The VA — What You Need To Know

    Merck’s recent announcement that its infliximab biosimilar, Renflexis, was awarded a U.S. Department of Veterans Affairs (VA) national contract has sparked curiosity about the potential influence this might have on biosimilar adoption and formulary preference in the rest of the market. Renflexis was determined to be the lowest-priced infliximab proposed under a competitive solicitation and, as such, was awarded preferred use as the only infliximab option covered on the VA National Formulary (VANF).

  • Cardiac Stem Cell Controversy — 3 Important Lessons Learned
    Cardiac Stem Cell Controversy — 3 Important Lessons Learned

    Heart problems have touched many of our lives, or the lives of those we care about. Heart attacks and heart failure are leading killers in the U.S.,1 with limited treatment options available today. Typically, a heart attack is followed by significant heart muscle cell death, leaving the organ in a weakened state and the patient at risk of cardiovascular dysfunction and eventual heart failure. This leads to many of the deaths attributed to cardiovascular disease.

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PHARMA OUTSOURCING WHITE PAPERS

Utilizing External Collaboration To Accelerate Vaccine Development Utilizing External Collaboration To Accelerate Vaccine Development

Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

The Role Of Pharmaceutical Packaging Partners In Times Of Growth

The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont

Pharma Production Tech Transfers: Reaping Rewards, Reducing Risks

Transferring production — and the technologies that undergird it — can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.

Low Particulate Carboys Can Help Improve Biopharma And Vaccine Production

Some products cannot be filtered prior to final fill, requiring a process which limits particulate-contributing factors wherever possible. Pre-cleaned, sterile, ready-to-use containers ease this burden.

Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

By William Whitford, Strategic Solutions Leader, BioProcess, GE Healthcare Life Sciences

The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

The Scientific Path To Cycle Development

Management of medication delivery through lyophilization - freeze-drying - is a crucial enabling process technology for many important parenteral drugs. Close to 50% of biopharmaceuticals, including enzymes, proteins and monoclonal antibodies, must be lyophilized as these therapeutic agents are insufficiently stable for ready-to-use solution dosage forms. A small but growing number of small-molecule drugs are also prepared in this manner. It is a safe bet that without lyophilization, the majority of these products would not be available.

Proteinase K Production: Single-Use vs. Stainless For Microbial Fermentation

In this study, the native production and titer activity for secreted Proteinase K from Tritirachium album (T. album) during the course of an 11-day culture were compared between the S.U.F. and stainless steel fermentor systems.

Downstream Protein Purification Technical Note

Integrate sterile and efficient temperature control with the DHX Heat Exchanger. The purpose of this tech note is to present the benefits of the Thermo Scientific DHX Heat Exchanger and its applications.

The Evolution Of A Partnership
The Aptuit acquisition of Evotec’s Chemical Development business in 2007 proved to be the catalyst for a collaborative relationship that now extends beyond its original scope. Today Evotec is partnering with Aptuit across multiple business lines. By Aptuit
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Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

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About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

Trade and Channel Strategies 2018 December 11 - 12, 2018
Philadelphia, PA)
Adverse Event Reporting: Avoiding Common Pitfalls December 11 - 11, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
Specialty Product Data Strategies December 12, 2018
Philadelpia, PA)
Copay Accumulator Summit December 13, 2018
Philadelphia, PA)
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